Events

Rappel de Pressure Tourniquet Cuffs

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Stryker Sustainability Solutions.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75221
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0324-2017
  • Date de mise en oeuvre de l'événement
    2016-09-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149691
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Tourniquet, pneumatic - Product Code KCY
  • Cause
    Issue with the process for detection of leaking pressure tourniquet cuffs (ptc). leaking ptc devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic during bier block requiring medical intervention.
  • Action
    Stryker Sustainability Solutions sent an Customer Notification letter September 19, 2016. Customers were instructed to discontinue use of the affected products. The letter stated to follow the link below to complete the Recall Effectiveness Check Form and indicate if any devices containing expiration dates from May 2016-May 2018 remain in inventory. This form must be completed even if no affected product is found. Use the following reference number as you complete the form: [Ship to Account #] If the form indicates that any affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Credit for all affected devices returned will be issued to the facility. .Adverse reactions or quality problems experienced with the use of this product may be reported to: o Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433 X5555 o http://www.stryker.com/productexperience/ o The FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Device

Pressure Tourniquet Cuffs
  • Modèle / numéro de série
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    U.S. distribution nationwide. No foreign distribution
  • Description du dispositif
    Reprocessed Pressure Tourniquet Cuff (PTC) || Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • Adresse du fabricant
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA